Personalized Information or Basic Information in Helping Patients Make Decisions About Participating in a Clinical Trial
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ClinicalTrials.gov Identifier: NCT00750009 |
Recruitment Status
:
Completed
First Posted
: September 10, 2008
Last Update Posted
: August 21, 2013
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RATIONALE: Providing information that is tailored to answer patients' questions about clinical trials may help patients with cancer decide to enroll in a clinical trial. It is not known whether providing personalized information is more effective than basic information in helping patients make decisions about clinical trials.
PURPOSE: This randomized phase III trial is studying personalized information to see how well it works compared with basic information in helping patients make decisions about participating in a clinical trial.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Unspecified Adult Solid Tumor, Protocol Specific | Other: educational intervention | Phase 3 |
OBJECTIVES:
Primary
- To improve preparation for consideration of clinical trials by providing tailored information to address barriers related to knowledge, goals and values, and beliefs and expectancies before their physician visit in patients with advanced metastatic or early stage cancer.
Secondary
- To develop and pilot test a tailored interactive preparatory aid (PRE-ACT) to promote informed cancer treatment decision making by addressing barriers to considering clinical trials as a treatment option.
- To evaluate the efficacy of PRE-ACT in improving preparation for considering participation in clinical trials by conducting a randomized clinical trial to compare PRE-ACT vs generic clinical trial information with text (control condition).
- To investigate relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes.
- To investigate the impact of PRE-ACT on patient decisional conflict, satisfaction with information received, satisfaction with discussion about clinical trials with the physician, satisfaction with the treatment decision, clinical trials discussion, clinical trials participation, and quality of informed consent.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (PRE-ACT): Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
- Arm II (control): Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
All patients complete a baseline assessment to assess demographics, personal characteristics, preparedness, and barriers to clinical trials. All patients also undergo a post-intervention assessment and complete a survey to measure preparedness for consideration of clinical trials, and impact of the intervention on clinical trials barriers. A brief patient post-consultation assessment is completed by patients within two weeks of the physician consultation to determine whether clinical trials were discussed, patient satisfaction with discussion about clinical trials, treatment options, treatment selection, decisional conflict, and satisfaction with treatment decision. Quality of informed consent is also assessed for patients participating in a clinical trial and completing the consent process during their initial physician consultation. Each patient's physician completes a brief Physician Post-Consultation Assessment to define cancer stage, treatment goal, and to determine whether clinical trials were offered and accepted and if not, why not. For patients who have not made a treatment decision after consultation, a brief follow-up phone survey or medical chart review is used to identify the patient's treatment choice.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 583 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | Preparatory Aid to Improve Decision Making About Cancer Clinical Trials (PRE-ACT) |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I (PRE-ACT)
Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
|
Other: educational intervention
Patients receive a tailored intervention or generic information
|
Active Comparator: Arm II (control)
Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
|
Other: educational intervention
Patients receive a tailored intervention or generic information
|
- Improvement in preparation for consideration of clinical trials [ Time Frame: after pts.complete all survey measures ]
- Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT) [ Time Frame: after pts.complete all survey measures ]
- Efficacy of PRE-ACT [ Time Frame: after pts.complete all survey measures ]
- Comparison of PRE-ACT and genomic clinical trial information with text [ Time Frame: after pts.complete all survey measures ]
- Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes [ Time Frame: after pts.complete all survey measures ]
- Impact of PRE-ACT on patient [ Time Frame: after pts.complete all survey measures ]To investigate the impact of PRE-ACT on patient decisional conflict, satisfaction with information received, satisfaction with discussion about clinical trials with the physician, satisfaction with the treatment decision, clinical trials discussion, clinical trials participation, and quality of informed consent. (Exploratory Aim)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Diagnosis of 1 of the following:
- Advanced (metastatic) disease
- Early stage (i.e., appropriate for adjuvant therapy) disease
- Scheduled for first outpatient consultation with a medical oncologist at the Clinical Centers
PATIENT CHARACTERISTICS:
- Able to read and verbally communicate in English
- Patients who choose to complete the intervention at home rather than at the Clinical Center before their visit must have high-speed (i.e., DSL or cable) Internet access
PRIOR CONCURRENT THERAPY:
- Not specified

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750009
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Ohio | |
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106 | |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19111-2497 |
Principal Investigator: | Neal J. Meropol, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Case Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00750009 History of Changes |
Other Study ID Numbers: |
CASE18Z09 R01CA127655 ( U.S. NIH Grant/Contract ) P30CA006927 ( U.S. NIH Grant/Contract ) FCCC-08808 ( Other Identifier: Fox Chase Cancer Center ) |
First Posted: | September 10, 2008 Key Record Dates |
Last Update Posted: | August 21, 2013 |
Last Verified: | August 2013 |
Keywords provided by Case Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia |
chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia juvenile myelomonocytic leukemia mast cell leukemia meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia |
Additional relevant MeSH terms:
Lymphoma Disease Syndrome Leukemia Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Nervous System Neoplasms Central Nervous System Neoplasms Myeloproliferative Disorders Plasmacytoma Lymphoproliferative Disorders Myelodysplastic-Myeloproliferative Diseases |
Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neoplasms by Site |